Creativity needs room to roam, but regulatory needs confidence and limits: how to make them get along? Liz Ruby of RBK Healthcare Marketing gives some riding lessons.

1. P R E S E N T A T I O N
(Without Knocking Down the Regulatory Fence)
Liz Ruby
Co-founder, Partner
RBK Healthcare Marketing

8. • Decrease the dread
• Do our due diligence
• Increase our situational awareness
• Be realistic about timing
• Build relationships early and often

11. • Risk management
• “First do no harm”
• Ensure consistency

14. • Agencies: “Our concepts will be
crushed!”
• PRCs: “Marketers will be unprepared!”
• Product managers: “My initiative will
fizzle out!”

16. • API: consciously choosing to assume
that colleagues operate in the best
interest of the company
• Opens up the conversation: can explore
differences/concerns from place of
curiosity rather than conflict

18. • “Yes” at one time (in one context) does
not mean “yes” forever
• Solid, vetted substantiation
• Know the piece inside and out
• And …

21. • PRC members:
– Pharmacists
– Nurses
– Physicians
– Lawyers
– Quality control
• Not marketers

22. • Provide context
– Purpose
– Target audience
– Distribution channels
– Desired outcome
• Move review up the chain of command when
appropriate
• Have realistic turnaround expectations for
review

24. • Wrangle references
– Research needs rigorous for new
claims/launches
• Multiplier effect: acute on large projects
• Uploading
• Entire process can be time-consuming

26. • Concept review: get ideas in front of
reviewers in the early stages
• Agency participation: give us a seat at
the table to hear feedback and probe
for clarity